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Nutrition Intervention
Personalized Nutrition Intervention for Gestational Diabetes (DESI-GDM Trial)
N/A
Recruiting
Led By Russell J de Souza, ScD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
DESI-GDM Trial Summary
This trial will assess the impact of a culturally tailored, personalized nutrition intervention on glycemic response to an oral glucose load in high-risk pregnancies of South Asian women.
Who is the study for?
This trial is for South Asian women between 12-18 weeks pregnant, at risk of gestational diabetes due to factors like age over 29, poor diet, family history of diabetes, or previous gestational diabetes. They must have a single pregnancy and be willing to modify their diet.Check my eligibility
What is being tested?
The study tests a personalized nutrition plan tailored to cultural preferences against a control group with standard advice. It aims to see if the special diet can improve blood sugar levels after an oral glucose test in both mother and infant.See study design
What are the potential side effects?
Since this is a dietary intervention rather than medication, side effects are minimal but may include changes in digestion or food sensitivities as the participants adjust to new eating habits.
DESI-GDM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glucose area-under-the-curve (glucose AUC)
Secondary outcome measures
Gestational diabetes mellitus
Other outcome measures
Maternal blood pressure
Maternal pregnancy complications
DESI-GDM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Dietary InterventionExperimental Treatment1 Intervention
A personalized nutrition plan will be developed for each woman and will respect faith-based food choices and regional preferences. The plan will be delivered by a culturally congruent health coach, and consider baseline dietary intake, energy balance for recommended gestational weight gain, personal values and preferences, through setting 2-4 "SMART" goals. Participants assigned to the intervention group will receive text messages. Participants assigned to the intervention group will be given a Fitbit to track their steps and will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.
Group II: ControlActive Control1 Intervention
Participants in the control group will receive simple text messages weekly, aimed at increasing walking. They will be given PDF resources that provide advice on healthy eating, physical activity, and other lifestyle factors during pregnancy plus additional materials adapted specifically for the South Asian community.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dietary Intervention
2014
Completed Phase 2
~2550
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
884 Previous Clinical Trials
2,598,126 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
368 Previous Clinical Trials
300,811 Total Patients Enrolled
Population Health Research InstituteOTHER
155 Previous Clinical Trials
679,722 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I often feel very nauseous or vomit a lot.I am not willing to change my diet.You are pregnant with only one baby.You have a higher chance of having complications during pregnancy, like having twins, using fertility treatments, or having certain health conditions.I am over 29, have a poor diet, a family history of diabetes, had gestational diabetes, or my BMI is over 23.17.You are currently pregnant and have ancestors from South Asia.Your blood pressure is higher than 140 over 90.I have diabetes.I am not willing to walk.You are in weeks 12 to 18 of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Dietary Intervention
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please clarify if this research is recruiting participants?
"This clinical trial is presently recruiting participants. Its listing on clinicaltrials.gov dates back to November 26th 2020, with the most recent edit occurring on April 28th 2022."
Answered by AI
What is the primary aim of this experiment?
"In the span of three months, this experiment will assess completion rate as its primary purpose and delving into gestational diabetes mellitus, birthweight, and sum-of-skinfolds as secondary outcomes. Gestational diabetes is classified through fasting glucose levels that exceed 5.2 mmol/L or 2 hour post-load level exceeding 7.2 mmol/L; birthweights are measured to the nearest 10g with a digital weight scale while sum-of skin folds are determined by measuring to the nearest 0.2 mm with calipers in order to evaluate body density, fat content and FFM (fat free mass)."
Answered by AI
How many individuals are participating in this research endeavor?
"Affirmative. According to details hosted on clinicaltrials.gov, this experiment is currently recruiting applicants and was first published on November 26th 2020 with most recent updates from April 28th 2022. The number of patients needed for the trial stands at 190 in two distinct medical centres."
Answered by AI
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